BEUDAMED
    FDA Enforcement Class II Terminated

    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.

    Recall: Z-2115-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2115-2014
    Event ID
    68703
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heartsine Technologies, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    June 12, 2014
    Classification Date
    July 24, 2014
    Termination Date
    April 16, 2015
    Address
    203 Airport Road West, Belfast, N/A, United Kingdom

    Description

    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.

    Reason

    A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.

    Code Info

    Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.

    Distribution

    Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.

    Quantity

    3245